Arrangements and methods for effecting an endoluminal anatomical structure

ABSTRACT

Exemplary embodiments of devices and method for affecting at least one anatomical tissue can be provided. A configuration can be provided that includes a structure which is expandable (i) having and/or (ii) forming at least one opening or a working space through which the anatomical tissue(s) is placed in the structure. For example, the structure, prior to being expanding, can have at least one partially rigid portion. In addition, or as an alternative, upon a partial or complete expansion thereof, the structure can be controllable to have a plurality of shapes. Further, the structure can be controllable to provide the working space with multiple shapes and/or multiple sizes.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims priority from U.S. Provisional PatentApplication No. 61/287,077, filed Dec. 16, 2009, the disclosure of whichis incorporated by reference in its entirety herein.

FIELD OF THE DISCLOSURE

Exemplary embodiments of the present disclosure relate to arrangementsand methods for effecting an endoluminal anatomical structure, and moreparticularly to arrangements and methods for treatment ofgastrointestinal lesions that currently require open abdominal surgery.The exemplary embodiment of at least one of the arrangements can providean endoluminal colon chamber and a variety of maneuverable operatingtools inside that chamber. For example, the exemplary embodiment of sucharrangement can function as a miniature operating room inside the colon.

BACKGROUND INFORMATION

Current endoscopic technologies may not facilitate treating colonperforations, large polyps and tumors, and a significant colon bleedingeffectively and safely. A gastrointestinal bleeding is a common andpotentially life-threatening medical condition, which can complicate anypolypectomy (polyp removal), and excision of colonic tumors. A colonperforation can occur when excessive mechanical force or excessiveenergy is inadvertently applied to a colonic wall. A colon perforationis a life-threatening condition and currently requires major emergencysurgery to close the colon perforation and preclude fecal contaminationof an abdominal cavity and resulting sepsis.

Consequently, many patients who develop large polyps, colon perforation,colon bleeding and other significant colon pathology currently have toundergo a major surgery and endure a significant operative trauma and,typically, painful and prolong recovery. Currently there are noeffective and safe devices and methods for replacing major abdominalsurgery in case of colon perforation or when large wide-based polypsneed to be removed.

Thus, there may be a need to address at least some of the deficienciesdescribed herein above.

U.S. Provisional Patent Application Ser. No. 61/247,605 filed on Oct. 1,2009 and entitled “Detachable Balloon Catheter” describes exemplaryembodiments of device and method for treatment of a gastrointestinalperforation and/or a gastrointestinal bleeding. The exemplary device caninclude a balloon catheter that can control bleeding by pressing on ableeding area or/and prevents the gastrointestinal contents trespassingoutside a gastrointestinal lumen into a body cavity by blocking anopening in the luminal wall or blocking the colon distal to theperforation. Such exemplary device can be inserted using an endoscope,and can allow a partial or complete withdrawal of an endoscope, whileleaving the balloon at the target area. More specifically, the exemplarydevice and method can facilitate ceasing a colonic bleeding and blockinga colon perforation.

The Minos Megachannel is a large bore flexible reinforced tube, which isdesigned to be inserted over the standard colonoscope. After thecolonoscope is removed, the tube can be used as a passage for insertionof different instruments into the colon.

Further, conventional endoscopes generally have one to two workingchannels, which likely do not have independent movements from the mainbody of the endoscope. As a result, when conventional flexibleendoscopic instruments are inserted via such channels into theintestinal lumen, an operator can only manipulate these instrumentsaxially (e.g., forward and backward movements), and possibly somewhatrotationally. In addition, since the conventional instruments can onlybe advanced from the tip of the endoscope towards the target lesionaxially and in front of the endoscopic image, the conventionalinstruments have only limited functionality.

Accordingly, there may be a need to address at least some of thedeficiencies described herein above.

SUMMARY OF EXEMPLARY EMBODIMENTS OF THE PRESENT DISCLOSURE

Exemplary embodiments of the present disclosure can address most if notall of the above-described needs by providing device and method for atreatment of, e.g., a gastrointestinal perforation, bleeding, removal oflarge polyps, and/or other significant endoluminal pathology, forexample, colonic pathology.

According to one exemplary embodiment of the present disclosure, thedevice can function as a miniature operating room inside the lumen, forexample, colon, and providing an operator with advanced endoluminalfunctionalities replicating capabilities of a surgical suite. Theexemplary device of the present disclosure can provide such miniatureendoluminal operating room, chamber or at least partial enclosure, andthe ability to utilize a variety of articulating surgical instruments,which can operate within, at or around the chamber.

According to one exemplary embodiment of the present disclosure, theexemplary arrangement/device can be introduced after a standarddiagnostic colonoscopy is performed. An exemplary balloon guidecatheter, as described in U.S. Provisional Patent Application Ser. No.61/247,605, or a large endoluminal channel such as a Minos Megachannelmanufactured by, e.g., Minos Inc., can be used to facilitate theinsertion of the exemplary device according to the present disclosure.

In another exemplary embodiment of the present disclosure, thearrangement/device can contain a plurality (e.g., three) primarysections, e.g., a handle, a multi-lumenal tube, and an expandablechamber.

It is possible to utilize endoluminal channels and associatedarticulating endoluminal instruments with the exemplary embodiments ofthe arrangement/device. To that end, the exemplary arrangement/devicecan include a multi-lumen tube. The multi-lumen tube can include lumensfor at least two special tools or tool-channels, or three or morespecial tools and/or tools-channels. In addition, the multi-lumen tubecan include other channels, which can be used for, as an example, air,water, vacuum delivery, etc. The exemplary arrangement/device can alsoinclude channel for scope and illumination; and lumens for a chamberactivation and lumen for a balloon guide catheter as indicated herein.

According to still another exemplary embodiment of the presentdisclosure, the arrangement/device may also contain a chamber locateddistally, which can be expanded to different sizes within the colon,thus producing a relatively large working space near the targetedluminal lesion. The exemplary arrangement/device can be structured tomanipulate the tools and/or tool-channels in such a way that distal endsof one or more of such tools and/or channels can operate within or atthe chamber, and approach the lesion from multiple or even alldirections, and using numerous angles. In addition, at least onetool-channel can accommodate a large diameter tool, for example, aspecial endoscopic stapler.

In a further exemplary embodiment of the present disclosure, thearrangement/device can further contain a control handle, e.g., at orabout its proximal end. The handle can be provided in a similar wayand/or shape as handles of other endoscopes', while including furthermore ports, such as, e.g., tool-channels ports, a balloon guide catheterport, a special lever to control the opening and closing of the devicechamber, etc.

According to a still further exemplary embodiment of the presentdisclosure, the arrangement/device can include and/or utilize particulartools or tool-channels. For example, the distal ends of the particulartools and/or tool-channels can be operated in all directions and withinall degrees of freedom using the actuating mechanisms, which can becontrolled at or about the proximal ends of the device. The exemplaryinstruments/tools (e.g., grasper(s), scissor(s), dissector(s), others),which can be inserted in the special tools or tool-channels, may bemanipulated (e.g., rotated, moved axially forward and backward, bent atthe distal end at any desired angles) by manipulating the tool-channels.

In a further exemplary embodiment of the present disclosure, thearrangement/device can facilitate a lateral and/or multi-directionalmovements of the instruments/tools, in addition to the axial androtational movements thereof. Since the exemplary tool-channels can bemanipulated independently from the main endoscope and othertool-channels, the instruments/tools can approach the lesion from thedifferent and possibly limitless directions. For example, when theendoscopic instruments/tools approach the lesion from the sides inrelation to the main longitudinal axis and, hence, without blocking theendoscopic image, a so-called and well-known in laparoscopy“tri-angulation” can be achieved. The tri-angulation can be a preferabletechnique for achieving the endoscopic arrangement's/device's improvedfunctionality and safety. Such exemplary methodology can mimic thefunctionality of well-established surgical operating room environments.The exemplary tool-channels can be advanced in the lumen from theworking ports of the multi-lumen tube and/or be at least partiallypre-fixed to the element(s) of the associated expandable chamber. Theexemplary tool-channels can also be advanced directly into the bodylumen (e.g., an intestinal lumen), into the chamber space, and/orinitially advanced along the element(s) of the chamber and then furtherinto the body lumen or into the chamber space.

As an alternative according to yet another exemplary embodiment of thepresent disclosure, the arrangement/device, alternatively to thetool-channels or in combination with the tool-channels, can useconventional and/or articulating instruments/tools with at least twodegree of freedom.

In addition, according to a further exemplary embodiment of the presentdisclosure, a method can be provided for using the exemplaryarrangement/device in the body lumen (e.g., colon). For example, usingsuch exemplary method, it is possible to perform a standard colonoscopyand identify a lesion that may not be treated using standard endoscopyand techniques. A balloon guide catheter can be inserted, the ballooninflated and the standard colonoscope (the balloon catheter and inflatedballoon are left in place) removed. The balloon guide catheter can beused as a guide-wire to facilitate the insertion of the exemplaryarrangement/device. The exemplary arrangement/device can be insertedover the balloon guide catheter, e.g., until the chamber is in theproximity to the lesion. The chamber can be deployed and adjusted tocertain dimensions. It is possible to readjust the chamber during theprocedure, as needed. Further, an operative area can be cleaned with aprovided suction catheter. Further, a proximal balloon, a distal balloonor both proximal and distal balloons can be inflated for the treatmentarea isolation. Tool-channels can be inserted, followed by or inconjunction with an insertion of the instruments/tools into thetool-channels. It is also possible to manipulate the tool-channels tooptimize and facilitate the instruments'/tools' approach to the lesion.Further, a procedure can be performed, for example, closing a colonicperforation, removing a large colon polyp or tumor, stopping a bleeding,closing diverticuli, removing an appendix, treating other body luminallesions.

Further, exemplary embodiments of devices and method for affecting atleast one anatomical tissue can be provided. A configuration can beprovided that includes a structure which is expandable (i) having and/or(ii) forming at least one opening or a working space through which theanatomical tissue(s) is placed in the structure. For example, thestructure, prior to being expanding, can have at least one partiallyrigid portion. In addition, or as an alternative, upon a partial orcomplete expansion thereof, the structure can be controllable to have aplurality of shapes. Further, the structure can be controllable toprovide the working space with multiple shapes and/or multiple sizes.

According to yet another exemplary embodiment of the present disclosure.prior to the structure being expanded, the structure can have at leastone partially rigid portion that is expandable to form anon-cylindrically-shaped working area which can be asymmetrical.Further, an endoscopic arrangement can be included that is structured tobe provided in the working area, and that can include a furtherconfiguration that facilitates an articulation of a tip portion of theendoscopic arrangement within the working area. The furtherconfiguration can include a mechanical bending arm which can facilitatethe tip portion to be moved within the working area so as to facilitatea visualization of at least one object in the working area. Anarrangement can also be provided which is coupled to the structure, andwhich can provide (i) at least one lumen and/or (ii) at least oneinstrument there through to reach the working area. For example, adistance between a tip of the arrangement and a distal portion of thestructure that is farthest away from the arrangement can be controllableto adjust a shape and/or a size of the working area.

In still another exemplary embodiment of the present disclosure, upon acomplete or partial expansion of the structure, the structure can becontrollable to have a plurality of shapes. In addition, the structurecan be controllable to provide the working space with multiple shapesand/or multiple sizes. The structure can have an expanded portion and anunexpanded portion, and form an axes of extension of the device, a firstdistance to a highest point of the expanded portion can be differentthan a distance to an non-expanded portion. For example, the firstdistance can be greater than the second distance. The structure can becontrollable to adjust the first distance, while maintaining the seconddistance approximately the same. Further, in an non-expanded state, theconfiguration can be controllable to provide an articulation thereof ina plurality of directions.

According to a further exemplary embodiment of the present disclosure, afirst arrangement can be provided at a distance from the configurationand the anatomical structure(s). In addition, a second arrangement canbe provided between the first arrangement and the configuration, and canhave at least one lumen that is connected to the first arrangement.Further, a third arrangement can be provided which may be structured tomove through the lumen at or near the anatomical structure(s), and whichcan be configured to be provided in the structure. The lumen(s) cancomprise a multi-channel tube, and the structure can be structured to bemovable through the multi-channel tube and rigidly connected thereto soas to limit or reduce a movement of the structure with respect to themulti-channel tube. At least one movable camera and an illuminationarrangement can be provided within or near the configuration, andmovable through the multi-channel tube. At least one movable vacuumcatheter and/or irrigation catheter can be provided within or near thestructure, and movable through the multi-channel tube.

In one exemplary embodiment, the lumen(s) can comprise a tube channeland/or a tool channel, which is/are movable therein. The tool channelcan be axially movable, rotatable, and/or bendable, and can include atleast one wire which is configured to bend the tool channel. A distalend of the tool channel can be configured to reach any point inside ornear the structure. The tool channel can include at least one wire whichcan be usable to bend the tube or the tool channel at least in onedirection and in at least at one angle which is between 0 and 180degrees. For example, a distance between the working channel and thestructure can be controllable by moving at least one wire in the workingchannel toward and/or away from the structure. An endoscope can beprovided within or near the configuration, and movable through themulti-channel tube to reach the working space. The endoscope can includean image sensor provided on a flexible shaft to visualize at least oneportion of the tissue(s).

According to yet a further exemplary embodiment of the presentdisclosure, the structure can have at least one flexible strip or atleast one wire and/or two or more flexible strips or wires. At least oneof the strips or wires can have a pre-formed shape to provide thedesired geometry of the working space. In addition, at least one ballooncan be provided or two or more balloons. At least one of the balloonscan be an asymmetric shape and/or a symmetric shape. The balloon(s) canbe positioned proximal to the structure. According to one exemplaryvariant, a first balloon and a second balloon can be provided, where thefirst balloon is provided distally in relation to the structure, and thesecond balloon is provided proximally in relation to the structure. Thestructure can be composed of wires and/or a mesh. Such wires/mesh, priorto being expanded, can have (i) at least one partially rigid portion,(ii) upon a partial or complete expansion thereof, can be controllableto have a plurality of shapes, and/or (iii) can be controllable toprovide the working space multiple shapes and/or multiple sizes.

These and other objects, features and advantages of the exemplaryembodiment of the present disclosure will become apparent upon readingthe following detailed description of the exemplary embodiments of thepresent disclosure, when taken in conjunction with the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Further objects, features and advantages of the present invention willbecome apparent from the following detailed description taken inconjunction with the accompanying figures showing illustrativeembodiments of the present disclosure, in which:

FIGS. 1 a and 1 b, are schematic cross-sectional illustrations of anexemplary embodiment of an arrangement/device comprising a multi-lumenextrusion tube, and multiple tubes inside one large tube in accordancewith the present disclosure;

FIG. 2 a is a perspective view of an exemplary embodiment of thearrangement/device according to the present disclosure comprising whichincludes a nitinol strips chamber in an open position;

FIG. 2 b is a perspective illustration of the arrangement/device of FIG.2 a with the chamber formed by flexible strips in a closed position;

FIG. 2 b is a side view of the arrangement/device of FIG. 2 a with thechamber formed by flexible strips in another position;

FIG. 2 d is a side view of the arrangement/device of FIG. 2 a with anovertube covering the chamber that is in the closed position accordingto an exemplary embodiment of the present disclosure;

FIG. 2 e is a side view illustration of the arrangement/device of FIG. 2a with a scope that is provided in one of the working channels andfacilitating a field of view therefor according to another exemplaryembodiment of the present disclosure;

FIG. 3 is a perspective view of another exemplary embodiment of thearrangement/device according to the present disclosure which includesthe chamber made from two metal strips;

FIG. 4 is a side cross-sectional view of an exemplary embodiment of thearrangement/device according to the present disclosure which includesthe chamber made from two asymmetric balloons;

FIG. 5 is a perspective view of another exemplary of another exemplaryembodiment of the arrangement/device according to the present disclosurewhich includes the chamber made from one asymmetric balloon togetherwith the balloon guide catheter;

FIG. 6 is a perspective view of another exemplary of still anotherexemplary embodiment of the arrangement/device according to the presentdisclosure which includes the chamber made from metal wires braid;

FIG. 7 is a perspective view of a further exemplary of yet anotherexemplary embodiment of the arrangement/device according to the presentdisclosure which includes the nitinol strips chamber with two blockingballoons at both sides;

FIG. 8 is a side view of another exemplary of yet a further exemplaryembodiment of the arrangement/device according to the present disclosurewhich includes the chamber with cameras;

FIG. 9 a is a right side perspective view of another exemplary of afurther exemplary embodiment of the arrangement/device according to thepresent disclosure which includes a particular handle;

FIG. 9 b is a left side perspective view the exemplaryarrangement/device of FIG. 9 a;

FIG. 10 is a perspective view of yet another exemplary of yet anotherexemplary embodiment of the arrangement/device according to the presentdisclosure which includes a vacuum catheter;

FIG. 11 is a perspective view of yet another exemplary of anotherexemplary embodiment of the arrangement/device according to the presentdisclosure which includes a tool-channel;

FIG. 12 are different illustration of a preferred embodiment of stillanother exemplary of another exemplary embodiment of thearrangement/device according to the present disclosure which includes atool-channel elevator; and

FIG. 13 a perspective view of yet another exemplary of another exemplaryembodiment of the arrangement/device according to the present disclosurewhich includes the tool-channels inside the chamber thereof.

Throughout the figures, the same reference numerals and characters,unless otherwise stated, are used to denote like features, elements,components or portions of the illustrated embodiments. Moreover, whilethe subject disclosure will now be described in detail with reference tothe figures, it is done so in connection with the illustrativeembodiments. It is intended that changes and modifications can be madeto the described exemplary embodiments without departing from the truescope and spirit of the subject disclosure as defined by the appendedclaims.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

According to one exemplary embodiment of the present disclosure, adevice, an arrangement and a method can be provided for treatment of,e.g., conditions associated with body lumen(s) or/and cavities, forexample, gastro-intestinal conditions, including but not limited to agastrointestinal perforation, bleeding, large polyps or/and tumors,diverticuli, appendix, and others.

The exemplary embodiments of the arrangement/device according to thepresent disclosure can provide various functions, which may be the sameand/or similar to the surgical functions provided in the surgicaloperating room, therefore, thus representing a miniature operating roomwithin a lumen (e.g., of a body), such as, e.g., colon and allowing toreplace a major surgery, e.g., an open abdominal surgery.

For example, as shown in FIGS. 2 a and 2 b, the exemplary embodiment ofthe arrangement/device 1 according to the present disclosure can providean endoluminal chamber which can also be at least partial enclosure,such as, e.g., an endoluminal colon or an intra-colon chamber/enclosure,and include various maneuverable operating instruments and/or tools 11within the chamber 10. The exemplary arrangement/device 1 can beinserted after one or more relevant lesions is/are identified, e.g.,during standard colonoscopy. A particular balloon guide catheter 4,e.g., such as described in U.S. Provisional Patent Application Ser. No.61/247,605 filed on Oct. 1, 2009, or Mega-channel such as Minos Inc.Mega-channel, can be used to facilitate an insertion of the exemplaryarrangement/device 1.

According to certain exemplary embodiments of the present disclosure,the arrangement/device 1 can be a particularly-designed endoscope, suchas, e.g., a colonoscope. As shown in FIGS. 9 a and 9 b, according tocertain exemplary embodiments, the arrangement/device 1 can include,e.g., an exemplary handle 20 (see FIGS. (see FIGS. 9 a and 9 b), anexemplary multi-lumen tube 30 (see FIGS. 1 a, 1 b, 3, 7, 8 and 13), andan exemplary expandable chamber 10 (see FIGS. 5, 7, 10 and 13). Inaddition, the arrangement/device 1 can include standard and particularexemplary instruments/tools 11 (see FIGS. 8, 12 and 13) and/or exemplarytool channels (see FIG. 13).

As indicated herein above, the exemplary arrangement/device 1 caninclude the multi-lumen tube 30. Such exemplary multi-lumen tube 30 canbe made from a single extrusion polymer tube 31 having multiple lumens{see FIG. 1 a}, and/or made in a standard endoscopic equipmentconfiguration using a collection of single or multi-lumen tubes 32 ofdifferent sizes that are enclosed by a single, large, flexible tube 33(see FIG. 1 b). External and internal tubes can be simple polymer tubesand/or reinforced tubes or braided tubes, as known in the art. Theexternal tube 33 can have a diameter that is large enough to contain allinner tubes 32 provided for the exemplary arrangement/device 1. Theexemplary multi-lumen tube 30 can include at least one lumen, and, e.g.,possibly 2 to 4 or more lumens for 2 to 4 or more exemplaryinstruments/tools 11 and/or tool-channels 40, and possibly additionallumens, for example, for a air insufflation 34, water irrigation 35,vacuum 36, lumen for wiring and/or fibers for cameras and illumination37, lumen for a balloon guide catheter 4, lumen for chamber expansioncontrol 38, and/or lumen for proximal balloon inflation 39, as shown inthe exemplary embodiment of FIG. 1 b.

For example, according to particular exemplary embodiments of thepresent disclosure, the arrangement/device 1 can contain a distalchamber 10 that can be expanded to different sizes inside the colon,thus likely creating relatively large or sufficient working space nearthe lesion to be treated. The exemplary chamber 10 can provide a spacefor manipulations of multiple tools and/or tool-channels in such a waythat several tools can approach the lesion from all sides anddirections, as shown in, e.g., FIGS. 3, 7, 8 and 13. The exemplarymulti-lumen tube 30, e.g., having a diameter between 10 mm to 40 mm, canaccommodate at least one tool-channel, which can in turn accommodate,e.g., a non-standard instrument, for example, an endoscopic stapler,both having a sufficient size for a particular purposes thereof.

According to one exemplary embodiment of the present disclosure, theexemplary chamber 10 can be constructed from at least one, and possiblytwo or more flexible metal strips, fibers or wires 12, which can be madefrom a flexible material, such as, e.g., Nitinol, as shown in FIGS. 2a-2 e and 3. These exemplary strips, fibers or wires can be composed ofother materials as well, including but not limited to surgical plasticor other materials. The exemplary strips, fibers or wires 12 can besubstantially straightened (or slightly-to-moderately bent as neededduring steering the device through the lumen) when the chamber 10(providing a working space) is in non-deployed position (see FIGS. 2 aand 2 d), and are substantially bent when actuated by a control lever 23in the handle 20, hence, enlarging the chamber 10 and creating a largerworking space inside the colon, as shown in FIGS. 2 b, 2 c, 2 e and 3.For example, pushing or pulling the exemplary strips, fibers or strips12 can be performed with a tube 19 that can slide in the lumen 38 bypulling and/or pushing the tube 19 proximal end lever 23 in the handle20, as shown in FIGS. 2 a-2 e, 3, 9 a and 9 b. Further, the guidecatheter 4 can be inserted inside the tube 19. The exemplary strips 12can be covered by a soft polymer cover to avoid possible inner colontissue damage.

According to an exemplary embodiment of the present disclosure, as shownin FIGS. 2 a-2 e, the chamber 10 it can be deflected by pulling on theexemplary strips, fibers or wires 12, or the chamber 10 can be openedwhen the exemplary strips, fibers or wires 12 are pushed forward fromthe handle 30. In thus manner, the exemplary strips, fibers or wires 12increase working space with in the chamber 30 to facilitate theanatomical structure to be pulled into the chamber 10 by otherinstruments/tools 11 being manipulated from the handle 30, as describedin further details herein, and shown in, e.g., in FIG. 8.

Further, as shown in FIGS. 2 c and 2 e, the exemplary strips, fibers orwires 12 can be covered with a protective cover portions 70 so as toreduce damage being caused by the exemplary strips, fibers or wires 12when they are actuated to expand the chamber 10 (i.e., which causes theexemplary strips, fibers or wires 12 to push on the surrounding tissue).As shown in FIG. 2 d, the arrangement/device 1 can also include anovertube 65 which can be pushed forward toward the front of thearrangement/device 1 so as to cover the collapsed chamber 10 (e.g., tofacilitate insertion and removal and containing the specimen), andpulled back to prepare for the chamber 10 for its expansion. FIG. 2 eshows an illustration of the arrangement/device 1 of FIG. 2 a with ascope 60 (including a camera and at least one light illuminating source)that is provided in one of the working channels 40 and facilitating afield of view 54 for positioning and propelling the exemplaryarrangement/device 1.

When the instrument 1 reaches the desired position within the body, thescope 60 can be retracted inside the chamber 10, e.g., via the workingchannel 40 to facilitate visualization inside and/or near the chamber10. According to another exemplary embodiment of the present disclosure,an articulating scope (which can perform similar functions as that ofthe scope 60) can be provided through one or more of the workingchannels 40 into the chamber 10. Such articulating scope can beconfigured to illuminate and/or provide images of the anatomicalstructure and tools inside and/or near the chamber 10. The articulatingscope can have a distal portion that can rotate in 360 degrees and bendto provide an end part thereof so as to illuminate and visualize anyportion of the anatomical structure and the tools inside and/or near thechamber 10 at any angle.

In another exemplary embodiment of the present disclosure, as shown inFIG. 7, the strips 12 can be proximally connected to a first cap 14,which can be made from a solid material. The first cap 14 can havemultiple holes for most or all lumens 32. The strips 12 can also bedistally connected to a second cap 15 which can be smaller in diameterthan the first cap 14, to facilitate a passage of large specimens, forexample, polyps into the area of the chamber 10. The distal second cap15 can include a hole for insertion of the balloon guide catheter 4.Alternatively or in addition, the exemplary chamber 10 can be made fromtwo asymmetrical balloons 5, 16, as shown in the exemplary embodiment ofFIG. 4. For example, the balloons 5, 16 can create space for the chamber10 and the exemplary instruments/tools 11 when inflated. Alternativelyor in addition, the exemplary chamber 10 can be provided using theproximal balloon 16 and the distal balloon 5, being connected to oneanother via their attachment to the balloon guide catheter 4, as shownin FIG. 5. Further alternatively or in addition, the exemplary chamber10 can be provided by a braided metal wire net 17 having an opening 18at desired location, as shown in FIG. 6.

In another exemplary embodiment of the present disclosure, at least one,and possibly two or more balloons can be used with the chamber 10 thatis made from strips 12 made from a bendable material (e.g., metal). Theexemplary balloon(s) 5, 16 can assist in blocking and/or isolating thechamber 10 from the rest of the colon, hence, minimizing and/orpreventing the inflow and outflow of liquids and solids from and/or tothe chamber 10, while the exemplary strips 12 can provide asubstantially rigid and stable working space and facilitate treatment ofthe lesion. For example, as shown in FIG. 7, the first symmetric orasymmetric balloon 16 can be provided in proximal to the chamber 10 orthe position of the strips 12. The second balloon 5 can be provided atthe position that is distal to the strips 12. Alternatively, the secondballoon 5 that can be connected to the guide catheter 4.

According to still another exemplary embodiment of the presentdisclosure, the arrangement/device 1 can include at least one camera andan illumination apparatus to provide sufficient light to the area ofinterest. For example, camera or cameras and illuminating component canbe movable or fixed in the arrangement/device 1, for example, to thechamber 10. In one exemplary embodiment shown in FIG. 2 e, thescope/front camera 50 can be used to facilitate the insertion of thearrangement/device 1 into the colon. Referring to FIG. 8, e.g., at leastone, two or more additional and possibly fixed cameras 51 can bepositioned so to facilitate image capture at a location of the lesion.Exemplary field views 54 of the cameras 51 can overlap, and such overlapmay facilitate visualization if one or more instruments/tools blocks oradversely affects view of one of the cameras. For example, illuminationcan be provided by a variety of ways, e.g., by LEDs 52, 53. Exemplaryfront LEDs 52 can be used for the front camera 50, and in-chamber LEDs53 can be used for the illumination in or at the chamber 10.Alternatively or in addition, a conventional flexible endoscope, havingdistal bendable section, can be used instead of or together with thefixed camera(s) 51 and illumination via the LEDs 52, 53.

As shown in FIGS. 9 a and 9 b, the exemplary arrangement/device 1according to a further exemplary embodiment of the present disclosurecan include a control handle 20 at or about its proximal end. Theexemplary handle 20 can have similar shape and configuration withrespect to other conventional endoscope's handles, while likely havingadditional channel ports and actuators than standard endoscope. Forexample, the ports in the handle 20 can include at least one, andpossibly 2-4 or even more ports for the tool-channels 21, balloon guidecatheter port 22 and particular lever 23 to control the opening andclosing of the chamber 10. Additional ports can include, but not limitedto, a luer port 24 for a proximal balloon inflation, and a port 26 of avacuum catheter 25 or an irrigation catheter. The handle 20 can includeswitches 27, 28 for air insufflations, water irrigation and vacuumactivation, as well as switch (not shown) for switching camera(s)between frontal and inner locations.

As illustrated in FIG. 10, the exemplary arrangement/device 1 accordingto a still further exemplary embodiment of the present disclosure caninclude a vacuum catheter with a bent tip 25, inserted in a vacuum lumen36 through a vacuum port 26. The vacuum catheter can operate as astandalone (as describe herein), and/or may be inserted into toolchannel 40 and deflect. Further, the vacuum catheter can be manipulatedto reach all or most areas inside and around the chamber 10, hence,providing an access for elimination of liquids and solids from andaround the chamber 10. In another exemplary embodiment of the presentdisclosure, the chamber 10 can include bendable and steerable section,which can be actuated at the lever 23, which when pulled, the instrument1 is articulated, and when pushed, the chamber 10 is opened (orincreased in size). Thus, movements of the exemplary arrangement/device1 in the colon can be facilitated. According to a further exemplaryembodiment, a locking mechanism can be provided which can, e.g., rotateone or more times (e.g., counterclockwise or counter-clockwise) to lockthe lever 23.

According to still another exemplary embodiment of the presentdisclosure, the exemplary arrangement/device 1 can include theinstruments/tools 11 and/or tool-channels 40, as shown in FIG. 11. Whenthe exemplary instruments/tools 11 are inserted in the tool channels 40,distal ends 41 thereof change the position(s) and/or shapes of theinstruments/tools 11, for example, rotated, axially moved, bent atdesired angles, whenever the position and shape of the associated toolschannels 40 are changed, as shown in FIG. 12. The tool channels 40 canbe actuated and manipulated at or about proximal end of the exemplaryarrangement/device of the present disclosure. The describedmaneuverability of the tool-channels 40, for example, their distal ends41 provide and/or facilitate multidirectional and multiangular approachto the target lesion.

For example, the tool-channels 40 can include at least one, andpreferably two, three or more lumen tubes 42, which can be made ofpolymer, possibly having high torque-ability, low friction, connected ator about their distal ends to an additional section 41, which can have“elevators” 43. The exemplary polymer tube(s) 42 can be reinforced withother materials to change its/their structural or/and functionalproperties. The elevator 43 can be a flexible bendable section, made,e.g., from a laser cut nitinol tube 44, and/or actuated, e.g., bent,using one or two metal wires 45. The instruments/tools 11 can beinserted in the first (e.g., relatively large) lumen of the tube 42, andthe wire 45 can be inserted in the second (e.g., relatively small) lumenof the tube 42.

As shown in FIG. 13, the ability of the tool-channel tubes 42 to move,independently or simultaneously, axially (e.g., pushing, pullingdirections), rotate and bend using the elevator 43, facilitates theinstruments/tools 11 or/and the tool-channels 40 in reaching any pointwithin and around the chamber 10, and can provide possibly an unlimitedrange of instrumental freedom within the working space. For example, asshown in FIG. 11, the tool channel 40 can include one or more handles 46connected to the tube 42 at or about a proximal side of the tube 42, andcan be used for a manipulation of the elevator 43, and utilize a port 47for an insertion of the exemplary instrument/tool. 11. The exemplarytool-channel handle 46 can include a slider or knob 48 which can be usedto actuate, e.g., pull and release a wire 45, as shown in FIG. 12. Anystandard tool(s) can be used with the exemplary tool-channel(s) 40.Alternatively or in addition, articulating tools having maneuverabledistal ends, e.g., with at least two degrees of freedom, can be used.

According to yet a further exemplary embodiment of the presentdisclosure, a method for implementing the exemplary arrangement/device 1according to the present disclosure can be provided. Such exemplarymethod can be utilized as follows:

-   -   i. Perform a standard colonoscopy and identifying a lesion that        may not be treated using standard endoscopy and techniques.    -   ii. Insert a balloon guide catheter, inflating the balloon and        removing the standard colonoscope (the balloon catheter and        inflated balloon are left in place). The balloon guide catheter        can be used as a guide-wire to facilitate the insertion of the        exemplary arrangement/device 1.    -   iii. Insert the exemplary arrangement/device lover the balloon        guide catheter, until the chamber is in the proximity to the        lesion.    -   iv. Deploy and adjust the chamber 10 of the exemplary        arrangement/device 1 to preferred dimensions. Readjust the        chamber 10 during the procedure as needed.    -   v. Clean an operative area with a provided suction catheter. If        desired, inflate a proximal balloon, a distal balloon or both        proximal and distal balloons for the treatment area isolation.    -   vi. Insert the tool-channels.    -   vii. Insert the instruments/tools into the tool-channels.        Manipulate the tool-channels to optimize and facilitate the        instruments/tools approach to the lesion.    -   viii. Perform a procedure, e.g., closing a colonic perforation,        removing a large colon polyp or tumor, stopping a bleeding,        closing diverticuli, removing an appendix, treating other body        luminal lesions.

The foregoing merely illustrates the principles of the presentdisclosure. Various modifications and alterations to the describedembodiments will be apparent to those skilled in the art in view of theteachings herein. For example, more than one of the described exemplaryarrangements, radiations and/or systems can be implemented to implementthe exemplary embodiments of the present disclosure. It will thus beappreciated that those skilled in the art will be able to devisenumerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of thepresent disclosure and are thus within the spirit and scope of thepresent disclosure. In addition, to the extent that the prior artknowledge has not been explicitly incorporated by reference hereinabove, it is explicitly being incorporated herein in its entirety. Allpublications referenced herein above are incorporated herein byreference in their entireties.

1. A device for affecting at least one anatomical tissue, comprising: aconfiguration comprising a structure which is expandable and at leastone (i) having or (ii) forming at least one opening or a working spacethrough which the at least one anatomical tissue is placed in thestructure, wherein the structure at least one of: a. prior to beingexpanded, has at least one partially rigid portion, b. upon a partial orcomplete expansion thereof, is controllable to have a plurality ofshapes, or c. is controllable to provide the working space with at leastone of multiple shapes or multiple sizes.
 2. The device according toclaim 1, wherein, prior to the structure being expanded, the structurehas at least one partially rigid portion that is expandable to form anon-cylindrically-shaped working area.
 3. The device according to claim2, wherein the working area is asymmetrical.
 4. The device according toclaim 2, further comprising an endoscopic arrangement structured to beprovided in the working area, and including a further configuration thatfacilitates an articulation of a tip portion of the endoscopicarrangement within the working area.
 5. The device according to claim 4,wherein the further configuration includes a mechanical bending armwhich facilitates the tip portion to be moved within the working area soas to facilitate a visualization of at least one object in the workingarea.
 6. The device according to claim 2, further comprising anarrangement which is coupled to the structure, and which provides atleast one of (i) at least one lumen or (ii) at least one instrumentthere through to reach the working area, wherein a distance between atip of the arrangement and a distal portion of the structure that isfarthest away from the arrangement is controllable to adjust at leastone of a shape or a size of the working area.
 7. The device according toclaim 1, wherein, upon the partial or complete expansion of thestructure, the structure is controllable to have a plurality of shapes.8. The device according to claim 1, wherein the structure iscontrollable to provide the working space with at least one of multipleshapes or multiple sizes.
 9. The device according to claim 1, thestructure has an expanded portion and an unexpanded portion, andwherein, from an axes of extension of the device, a first distance to ahighest point of the expanded portion is different than a distance to annon-expanded portion.
 10. The device of claim 9, wherein the firstdistance is greater than the second distance.
 11. The device of claim10, wherein the structure is controllable to adjust the first distance,while maintaining the second distance approximately the same.
 12. Thedevice according to claim 1, wherein, in an non-expanded state, theconfiguration is controllable to provide an articulation thereof in aplurality of directions.
 13. The device according to claim 1, furthercomprising: a first arrangement provided at a distance from theconfiguration and the at least one anatomical structure; a secondarrangement provided between the first arrangement and theconfiguration, the second arrangement having at least one lumen that isconnected to the first arrangement; and a third arrangement which isstructured to move through the at least one lumen at or near the atleast one anatomical structure, and which is configured to be providedin the structure.
 14. The device according to claim 13, wherein the atleast one lumen comprises a multi-channel tube, and wherein thestructure is structured to be movable through the multi-channel tube andrigidly connected thereto so as to limit or reduce a movement of thestructure with respect to the multi-channel tube.
 15. The deviceaccording to claim 14, further comprising at least one movable cameraand an illumination arrangement provided within or near theconfiguration, and movable through the multi-channel tube.
 16. Thedevice according to claim 14, further comprising at least one movablevacuum catheter or at least one irrigation catheter provided within ornear the structure, and movable through the multi-channel tube.
 17. Thedevice according to claim 13, wherein the at least one lumen comprisesat least one of a tube channel or a tool channel, which is movabletherein.
 18. The device according to claim 17, wherein the tool channelis at least one of axially movable, rotatable, or bendable, and includesat least one wire which is configured to bend the tool channel.
 19. Thedevice according to claim 17, wherein a distal end of the tool channelis configured to reach any point inside or near the structure.
 20. Thedevice according to claim 17, wherein the tool channel includes at leastone wire which is usable to bend the tube or the tool channel at leastin one direction and in at least at one angle which is between 0 and 180degrees.
 21. The device according to claim 14, wherein a distancebetween the working channel and the structure is controllable by movingat least one wire in the working channel at least one of toward or awayfrom the structure.
 22. The device according to claim 14, furthercomprising an endoscope provided within or near the configuration, andmovable through the multi-channel tube to reach the working space. 23.The device according to claim 22, wherein the endoscope includes atleast one image sensor provided on a flexible shaft to visualize atleast one portion of the at least one tissue.
 24. The device accordingto claim 1, wherein the structure has at least one flexible strip orwire.
 25. The device according to claim 1, wherein the structure has twoor more flexible strips or wires.
 26. The device according to claim 25,wherein at least one of the strips or wires have a pre-formed shape toprovide the desired geometry of the working space.
 27. The deviceaccording to claim 1, further comprising at least one balloon.
 28. Thedevice according to claim 1, further comprising two or more balloons, atleast one of the balloons being asymmetric.
 29. The device according toclaim 1, further comprising two or more balloons, at least one of theballoons having a symmetric shape.
 30. The device according to claim 1,further comprising at least one balloon which is proximal to thestructure.
 31. The device according to claim 1, further comprising afirst balloon and a second balloon, wherein the first balloon isprovided distally in relation to the structure, and the second balloonis provided proximally in relation to the structure.
 32. The deviceaccording to claim 1, wherein the structure is composed of at least oneof wires or a mesh. a. prior to being expanded, has at least onepartially rigid portion, b. upon a partial or complete expansionthereof, is controllable to have a plurality of shapes, or c. iscontrollable to provide the working space in at least one of multipleshapes or multiple sizes.
 33. A method for effecting at least oneanatomical tissue, comprising: inserting a device in a body lumen or abody cavity, the device comprising a structure which is expandable andat least one (i) having or (ii) forming at least one opening or aworking space through which the at least one anatomical tissue is placedin the structure; positioning the structure in a non-deployed state ator near the at least one anatomical structure; deploying the structureby at least partially expanding the structure so that the at least oneanatomical structure is moved into the opening or the working space;inserting at least one instrument in at least one lumen of the device toreach the opening or the working space; and effecting at least onechange of the at least one anatomical structure in the opening or theworking space using the at least one instrument, wherein the structureat least one of a. prior to being expanded, has at least one partiallyrigid portion, b. upon a partial or complete expansion thereof, iscontrollable to have a plurality of shapes, or c. is controllable toprovide the working space in at least one of multiple shapes or multiplesizes.